Actinic KeratosesNCT03066843
Photodynamic Therapy Incubation Times for Actinic Keratosis
A study testing ALA (5-aminolevulinic acid) and Blue light therapy in people with Actinic Keratoses, run by Northwestern University at 1 site in United States.
Trial summary
This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA) photodynamic therapy with different incubation times for the treatment of actinic keratosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- ALA (5-aminolevulinic acid) and Blue light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who have been diagnosed with actinic keratosis.
- Subjects who by the investigator deem to be suitable for photodynamic therapy of the face or scalp.
- Males or females ≥ 18 years old
- Fitzpatrick skin types I-VI
- Subjects are in good health as judged by the investigator.
- Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
Who cannot join
- Subjects who by the investigator are not suitable for photodynamic therapy.
- Lesions suspicious or proven for skin cancer
- History of 2 or more ALA- PDT treatments within the past 6 months.
- Use of keratolytics within 2 days of initiation of treatment (e.g., >5% urea, glycolic acid, lactic acid, salicyclic acid)
- Cryotherapy within the past 2 weeks.
- Topical retinoids within the past 4 weeks
Show all 12Show fewer
- Procedures, such as microdermabrasion, ablative lasers, ALA-PDT, chemical peels, 5-fluorouraci, diclofenac, imiquimod within the past 8 weeks
- Systemic retinoids within the past 6 months
- Pregnant or breast feeding
- Uncooperative subjects or subjects with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- Subjects who are unable to understand the protocol or give informed consent.
- Subjects who in the opinion of the investigator are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: A Randomized Controlled Trial Evaluating 5-aminolevulinic Acid Photodynamic Therapy With Different Incubation Times for the Treatment of Actinic Keratosis
This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA) photodynamic therapy with different incubation times for the treatment of actinic keratosis.
Subjects who are interested in participating, currently living in the Chicago metropolitan area, and meet inclusion and exclusion criteria will be enrolled in the study. Subjects will be randomized to either 1) zero time ALA incubation or 2) 1 hour ALA incubation. Demographic and health data will be collected prior to treatment initiation. Three visits will be conducted: screening, treatment, and follow up visit at 8 weeks.
This study is a pilot study designed to determine feasibility of this procedure.
- Conditions
- Actinic Keratoses
- Being tested
- ALA (5-aminolevulinic acid), Blue light therapy
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALA (5-aminolevulinic acid)Drug
Also called Levulon kerastick
ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation
Blue light therapyDevice
Also called BLU-U® Blue Light Photodynamic Therapy Illuminator
Subjects will be exposed to blue light
| Study group | Role | What they receive |
|---|---|---|
| Zero incubation with ALA (5-aminolevulinic acid) | Experimental | Subjects will receive zero time of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy. Receives: Drug: ALA (5-aminolevulinic acid); Device: Blue light therapy |
| One hour incubation with ALA (5-aminolevulinic acid) | Experimental | Subjects will receive one hour of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy. Receives: Drug: ALA (5-aminolevulinic acid); Device: Blue light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of Actinic Keratosis (AK) lesions
The number of AK lesions will be counted by a live, blinded assessor at baseline and at Week 8 follow-up visit.
Measured: Baseline and 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start1 Mar 2017
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066843
- Sponsor's protocol ID
- STU00204459
- Status last verified
- Jun 2026
- First submitted
- 24 Feb 2017
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating 5-aminolevulinic Acid Photodynamic Therapy With Different Incubation Times for the Treatment of Actinic Keratosis
- ClinicalTrials.gov ID
- NCT03066843
- Acronym / sponsor ID
- STU00204459
- Conditions
- Actinic Keratoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA) photodynamic therapy with different incubation times for the treatment of actinic keratosis.
Subjects who are interested in participating, currently living in the Chicago metropolitan area, and meet inclusion and exclusion criteria will be enrolled in the study. Subjects will be randomized to either 1) zero time ALA incubation or 2) 1 hour ALA incubation. Demographic and health data will be collected prior to treatment initiation. Three visits will be conducted: screening, treatment, and follow up visit at 8 weeks.
This study is a pilot study designed to determine feasibility of this procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zero incubation with ALA (5-aminolevulinic acid) | Experimental | Drug: ALA (5-aminolevulinic acid), Device: Blue light therapySubjects will receive zero time of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy. |
| One hour incubation with ALA (5-aminolevulinic acid) | Experimental | Drug: ALA (5-aminolevulinic acid), Device: Blue light therapySubjects will receive one hour of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who have been diagnosed with actinic keratosis.
- Subjects who by the investigator deem to be suitable for photodynamic therapy of the face or scalp.
- Males or females ≥ 18 years old
- Fitzpatrick skin types I-VI
- Subjects are in good health as judged by the investigator.
Key exclusion criteria (12 listed)
- Subjects who by the investigator are not suitable for photodynamic therapy.
- Lesions suspicious or proven for skin cancer
- History of 2 or more ALA- PDT treatments within the past 6 months.
- Use of keratolytics within 2 days of initiation of treatment (e.g., >5% urea, glycolic acid, lactic acid, salicyclic acid)
- Cryotherapy within the past 2 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALA (5-aminolevulinic acid)Also: Levulon kerastickALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation | Drug | One hour incubation with ALA (5-aminolevulinic acid), Zero incubation with ALA (5-aminolevulinic acid) |
| Blue light therapyAlso: BLU-U® Blue Light Photodynamic Therapy IlluminatorSubjects will be exposed to blue light | Device | One hour incubation with ALA (5-aminolevulinic acid), Zero incubation with ALA (5-aminolevulinic acid) |
Primary outcome
Change in number of Actinic Keratosis (AK) lesions
Time frame: Baseline and 8 Weeks
The number of AK lesions will be counted by a live, blinded assessor at baseline and at Week 8 follow-up visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALA (5-aminolevulinic acid) and Blue light therapy in people with Actinic Keratoses, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of Actinic Keratosis (AK) lesions (time frame: Baseline and 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.